氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221496093149473614955781495190149433714951870.05
211.151494454149349914939760.05
单位质量响应值RSD%判断
133260.87133988.880.39数据可信
供试品溶液-2024041721批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
60min1120038-1200388.2987.726.098.307.726.09
2118098-1180988.1638.16
3113664-1136647.8577.86
4108253-1082537.4837.48
5107706-1077067.4457.45
6102277-1022777.0707.07
120min1233328-23332816.12915.146.5316.1415.156.54
2232346-23234616.06116.07
3216011-21601114.93214.94
4209754-20975414.49914.51
5226236-22623615.63815.65
6196799-19679913.60413.61
240min1437538-43753830.24528.947.7830.2828.987.78
2433353-43335329.95529.99
3410612-41061228.38328.42
4397069-39706927.44727.48
5462655-46265531.98132.02
6371074-37107425.65025.68
360min1626487-62648743.30643.157.3743.3943.227.37
2640324-64032444.26244.34
3636767-63676744.01644.09
4592695-59269540.97041.04
5692242-69224247.85147.93
6556892-55689238.49538.56
480min1814264-81426456.28656.556.9456.4356.706.94
2828202-82820257.24957.40
3844316-84431658.36358.51
4792406-79240654.77554.91
5900243-90024362.22962.38
6729373-72937350.41850.54
600min11019958-101995870.50469.246.3670.7469.466.36
21021901-102190170.63870.87
31028681-102868171.10771.34
4956182-95618266.09666.31
51082483-108248374.82675.07
6900624-90062462.25562.46
720min11182138-118213881.71580.015.6182.0580.345.61
21177008-117700881.36081.70
31186630-118663082.02582.36
41111205-111120576.81277.13
51235128-123512885.37885.74
61052611-105261172.76173.06
840min11328506-132850691.83290.195.0792.2990.645.07
21317404-131740491.06591.53
31356718-135671893.78394.24
41261445-126144587.19787.63
51370194-137019494.71495.20
61194136-119413682.54482.95
960min11459023-1459023100.854101.112.33101.45101.702.35
21477932-1477932102.161102.76
31488841-1488841102.915103.52
41470848-1470848101.672102.23
51483143-1483143102.522103.15
61396578-139657896.53897.07
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min11485061-1485061102.654103.180.89103.40103.920.86
21484607-1484607102.623103.37
31500463-1500463103.719104.47
41483554-1483554102.550103.27
51485760-1485760102.702103.49
61516463-1516463104.825105.50
1200min11478983-1478983102.234102.741.07103.14103.631.04
21473975-1473975101.888102.79
31491266-1491266103.083103.99
41475048-1475048101.962102.83
51482314-1482314102.464103.40
61516077-1516077104.798105.63
1320min11471067-1471067101.687102.331.02102.74103.380.99
21470948-1470948101.679102.74
31485932-1485932102.714103.78
41471624-1471624101.725102.75
51473863-1473863101.880102.97
61508854-1508854104.299105.29
1440min11464996-1464996101.267102.011.08102.48103.211.05
21466601-1466601101.378102.59
31484892-1484892102.642103.86
41463834-1463834101.187102.36
51469929-1469929101.608102.85
61503945-1503945103.960105.10
极限11466401-1466401101.364101.821.08102.72103.181.05
21466298-1466298101.357102.72
31478847-1478847102.225103.60
41460343-1460343100.946102.27
51463496-1463496101.163102.56
61502874-1502874103.885105.19
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221496487149951514973191495960149616014970880.10
211.151477813147950614786600.09
单位质量响应值RSD%判断
133430.30132615.250.44数据可信
供试品溶液-2024041721批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
60min1110786-1107867.6937.576.647.697.576.68
2108364-1083647.5257.52
3109970-1099707.6367.64
4104585-1045857.2627.26
5121194-1211948.4158.42
699538-995386.9126.91
120min1216031-21603115.00114.987.3115.0114.997.32
2203318-20331814.11814.13
3225974-22597415.69115.70
4207683-20768314.42114.43
5241405-24140516.76316.78
6199661-19966113.86413.87
240min1397594-39759427.60828.177.7627.6428.207.76
2368170-36817025.56525.60
3439171-43917130.49530.53
4396782-39678227.55227.58
5448295-44829531.12931.17
6384240-38424026.68126.71
360min1576937-57693740.06141.618.4940.1441.688.49
2534739-53473937.13137.20
3656874-65687445.61245.69
4598037-59803741.52641.60
5661791-66179145.95346.04
6566930-56693039.36639.44
480min1763906-76390653.04455.317.5853.1855.457.58
2722178-72217850.14650.27
3879975-87997561.10361.25
4809044-80904456.17856.31
5849265-84926558.97159.12
6755036-75503652.42852.56
600min1932091-93209164.72267.616.3664.9467.836.36
2900343-90034362.51862.72
31052287-105228773.06873.31
4989632-98963268.71868.94
51035526-103552671.90472.15
6931790-93179064.70164.91
720min11128548-112854878.36479.284.7478.6879.604.75
21066650-106665074.06674.36
31202490-120249083.49883.85
41150976-115097679.92180.24
51200048-120004883.32883.68
61101669-110166976.49776.80
840min11235569-123556985.79589.283.9386.2289.723.94
21228631-122863185.31385.72
31352510-135251093.91594.39
41288276-128827689.45589.90
51334264-133426492.64893.12
61275361-127536188.55888.98
960min11412076-141207698.05199.972.4598.61100.552.46
21410153-141015397.91898.45
31480351-1480351102.792103.41
41406409-140640997.65898.24
51481036-1481036102.840103.45
61448433-1448433100.576101.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min11504410-1504410104.463104.150.96105.17104.880.94
21497925-1497925104.012104.69
31483913-1483913103.039103.81
41486393-1486393103.211103.94
51503501-1503501104.399105.17
61523204-1523204105.768106.47
1200min11500049-1500049104.160103.770.73105.02104.650.71
21496598-1496598103.920104.76
31482445-1482445102.937103.86
41481572-1481572102.877103.76
51495859-1495859103.869104.79
61509821-1509821104.838105.70
1320min11499205-1499205104.101103.660.85105.12104.700.83
21491257-1491257103.549104.54
31477152-1477152102.570103.65
41482460-1482460102.938103.97
51494803-1494803103.795104.88
61512668-1512668105.036106.06
1440min11492114-1492114103.609103.731.00104.78104.920.98
21489590-1489590103.433104.58
31472259-1472259102.230103.46
41497640-1497640103.992105.18
51492957-1492957103.667104.90
61518449-1518449105.437106.62
极限11495432-1495432103.839103.180.71105.17104.530.69
21490980-1490980103.530104.83
31470941-1470941102.139103.53
41475410-1475410102.449103.79
51487032-1487032103.256104.65
61496077-1496077103.884105.22
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